SM_CASE Table

Information about the Oracle Empirica Signal configuration variables from the SM_CASE table.

Configuration Variable	Column	Description
(Case) Blinding Status	UNBLINDING_STATUS_VE	Study blinding status
(Case) Case Number	CASE_NUM	Case number
(Case) Conmed List	CONMED_LIST_DV	Concomitant medication list
(Case) Country of Incidence	COUNTRY_VE	Country in which the case occurred
(Case) Device Case YN	DEVICE_CASE_YN	Y/N: Case has at least one suspect device
(Case) Drug Case YN	DRUG_CASE_YN	Y/N: Case has at least one suspect drug
(Case) Followup Date	FOLLOWUP_DATE	Date of follow-up
(Case) Followup Number	REV	Case follow-up number
(Case) Initial Report Date	INIT_REPT_DATE	Date first reported
(Case) Listedness	LISTEDNESS_VE	Case listedness
(Case) Outcome	EVT_OUTCOME_VE	Case outcome
(Case) Patient Ethnicity	ETHNICITY_VE	Patient Ethnicity
(Case) Patient Height cm	PAT_HEIGHT_CM	Patient height in centimeters
(Case) Patient Weight Kg	PAT_WEIGHT_KG	Patient weight in kilograms
(Case) Pregnancy	PREGNANCY_VE	Pregnancy case (Yes/No/UNK/NA)
(Case) Protocol Number	PROTOCOL_NUM	Case protocol number
(Case) Report Type	REPORT_TYPE_VE	Type of report (spontaneous, clinical trial, etc.)
(Case) Seriousness Text	SERIOUSNESS_TEXT_DV	Seriousness text
(Case) Study Description	STUDY_DESC	Case study description
(Case) Study Name	BLIND_NAME	Study name
(Case) Study Number	STUDY_NUM	Case study number
(Case) Study Phase	DEV_PHASE_VE	Case study phase
(Case) Study Type	STUDY_TYPE_VE	Case study type
(Case) SUSAR Case YN	SUSAR_YN_VE	Y/N: SUSAR case
(Case) Vaccine Case YN	VACCINE_CASE_YN	Y/N: Case has at least one suspect vaccine
(Case) ValidEnd	VALIDEND	Valid end date
(Case) ValidStart	VALIDSTART	Valid start date
(Case/derived) AgeGroup3	AGE_GROUP_3_DV	Age group in years: 00_64, 65_ above, UNK
(Case/derived) AgeGroup4	AGE_GROUP_4_DV	Age group in years: 00_17, 18_64, 65_above, UNK
(Case/derived) AgeGroup9	AGE_GROUP_9_DV	Age group in years: 00_01, 02_04, 05_12, 13_17, 18_45, 46_64, 65_74, 75_above, UNK
(Case/derived) Event List	EVENT_LIST_DV	List of preferred terms. (S) indicates serious; (U) indicates unlisted for primary suspect drug. Listedness is determined by CDS listedness for trial reports, other- wise CORE listedness.
(Case/derived) Fatal YN	FATAL_YN_DV	Y/N: Case is fatal
(Case/derived) HCP YNU	HCP_YNU_DV	Y/N/U: Indicates if case has at least one reporter who is a Health Professional
(Case/derived) Last Significant Update	LAST_SIGNIF_UPDATE_DV	Date associated with the last significant follow-up for the case
(Case/derived) Last Significant Update Month	LAST_SIGNIF_UPDATE_ MONTH_DV	Subset month associated with the last significant follow-up for the case
(Case/derived) Last Significant Update Quarter	LAST_SIGNIF_UPDATE_ QUARTER_DV	Subset quarter associated with the last significant follow-up for the case. These quarters follow Schedule A.
(Case/derived) Last Significant Update Week	LAST_SIGNIF_UPDATE_WEEK_ DV	Subset ISO week associated with the last significant follow-up for the case
(Case/derived) Patient Age Years	AGE_YEARS_DV	Age converted to years
(Case/derived) Patient BMI	BMI_DV	Patient body mass index
(Case/derived) Patient Gender	GENDER_CLEAN_VE	Patient's sex (F/M/U) , with NULL converted to U
(Case/derived) Received Half Year	RECEIVED_HALFYEAR_DV	Half-year of initial date of report (e.g., 200306, 200312, etc.)
(Case/derived) Received Month	RECEIVED_MONTH_DV	Month of initial date of report (e.g., 200304)
(Case/derived) Received Quarter	RECEIVED_QUARTER_DV	Quarter-year of initial date of report (e.g., 200303, 200306, etc.)
(Case/derived) Received Year	RECEIVED_YEAR_DV	Year of initial date of report
(Case/derived) Seriousness YN	SERIOUSNESS_VE	Y/N: Case is serious
(Case/derived) STANDARD_ STRATA	STANDARD_STRATA_AG9_DV	Gender + agegroup9 + received year
(Case/derived) STANDARD_ STRATA_AG4	STANDARD_STRATA_AG4_DV	Gender + agegroup4 + received year
(Case/derived) STANDARD_ STRATA_ARGUS	STANDARD_STRATA_DV	Gender + ARGUS agegroup + received
(Case/derived) Subset_3Year_ Group	SUBSET_3YEAR_GROUP_DV	Data up to 2000 lumped together in a single group. Post 2000 categorizes reports into three year groups (as in [2001-2003]) based on the initial date
(Case/derived) Subset_Month	SUBSET_MONTH_DV	Month of initial date of report. Dates prior to 2000 grouped together into larger sets
(Case/derived) Subset_Quarter	SUBSET_QUARTER_DV	Quarter of initial date of report, following Schedule A. Dates prior to 2000 are grouped together into larger sets
(Case/derived) Subset_Week	SUBSET_WEEK_DV	I SO week of initial date of report. Dates prior to 2000 are grouped together into larger sets
(Case/derived) Subset_Year	SUBSET_YEAR_DV	Year of initial date of report. Dates prior to 2000 are grouped together into larger sets
(Case/derived) Suspect Drug List	SUSPDRUG_LIST_DV	List of suspect products. (P) indicates primary suspect product. * indicates company product
(Case/derived) Treatment List	TREATMENT_LIST_DV	List of treatment products